Development of a Telehealth Platform for Treatment With the SpeechVive Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Change in Caregiver Quality of Life
研究概览
简要总结
Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective. In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate. The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person. The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient. Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Difficulty communicating
- •Is currently being seen, or agrees to be seen, by a speech pathologist who fits the SpeechVive device and also has agreed to participate in the study
- •Has a regular caregiver living with him/her
排除标准
- •Neurological diagnoses (except Parkinson's disease)
- •Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
研究组 & 干预措施
Telemedicine group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device via the internet using the telemedicine application. Also includes speech-language pathologists providing treatment via the telemedicine application.
干预措施: Telemedicine interaction (Behavioral)
Telemedicine group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device via the internet using the telemedicine application. Also includes speech-language pathologists providing treatment via the telemedicine application.
干预措施: SpeechVive device (Device)
In person group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person. Also includes speech-language pathologists providing treatment in person.
干预措施: SpeechVive device (Device)
In person group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person. Also includes speech-language pathologists providing treatment in person.
干预措施: In person interaction (Behavioral)
结局指标
主要结局
Change in Caregiver Quality of Life
时间窗: Change from baseline after 6 months of treatment
Scale of Quality of Life of Care-givers
Depression: Caregiver Geriatric Depression Scale
时间窗: Change from baseline after 6 months of treatment
Geriatric Depression Scale
Change in Patient with PD Ratings of Communication Competence
时间窗: Change from baseline after 6 months of treatment
Communicative Participation Item Bank-Short Form
Change in Patient with PD quality of life
时间窗: Change from baseline after 6 months of treatment
Parkinson's Disease Questionnaire-39
Attractiveness of the telehealth platform.
时间窗: At monthly intervals during the study period (6 months for each patient)
Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients
Travel cost burden - in-person group
时间窗: At monthly intervals during the study period (6 months for each patient)
Survey requesting Patient/caregiver travel distances and durations
Impact of treatment on time - telemedicine group
时间窗: At monthly intervals during the study period (6 months for each patient)
Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment
Treatment adherence
时间窗: At monthly intervals during the study period (6 months for each patient)
Usage data from the SpeechVive and patient attendance at treatment sessions
Change in Vocal intensity level
时间窗: Change from baseline after 6 months of treatment
Sound pressure level from speech samples with and without the device in place
Change in Patient with PD Depression Level
时间窗: Change from baseline after 6 months of treatment
Geriatric Depression Scale Short form
Impact of Life Events for Patient with PD and Caregiver
时间窗: Change from baseline after 6 months of treatment
Change in Impact of PD on life satisfaction
Change in general self-efficacy
时间窗: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
次要结局
- Change in Speech rate(Change from baseline after 6 months of treatment)
- Change in Apathy(Change in baseline after 6 months of treatment for Patient with PD and Caregiver)
- Change in Pausing patterns(Change from baseline after 6 months of treatment)
- Change in Caregiver Burden(Change from baseline after 6 months of treatment)
- Change in Caregiver Ratings Patient's of Communication Competence(Change in baseline after 6 months of treatment)
- Change in Patient with PD Perceived Autonomy(Change in baseline after 6 months of treatment)
- Patient with PD satisfaction - telemedicine group(At the end of the study period (after 6 months))
- Caregiver satisfaction - telemedicine group(At the end of the study period (after 6 months))
- Patient with PD satisfaction - in person group(At the end of the study period (after 6 months))
- Caregiver satisfaction - in person group(At the end of the study period (after 6 months))
- Change in Patient with PD Participation in Social Activities(Change in baseline after 6 months of treatment)